A Double Blind, Randomized, Parallel Design Study to Evaluate the Effectiveness of Post-operative Dose of Alvimopan(Entereg) in Preventing Post-operative Ileus in Poly-traumatized Patients
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Recovery of bowel function in trauma patients who received post operative dose of Alvimopan compared to placebo.
研究概览
简要总结
To evaluate the efficacy and safety of Alvimopan(12 mg) in recovery of bowel function in an emergency trauma setting without the pre-operative dosage in patients that will receive abdominal surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages 18 to 80
- •Poly-traumatized patients
- •Extubated patients after abdominal exploration
- •Underwent Abdominal exploration, had colon resection with primary anastomosis with closure of abdomen
排除标准
- •Mechanically ventilated patients
- •Patient not expected to survive Glasgow Coma Scale = 3
- •Pregnant patients
- •Apache score > 40 (observed mortality 100%) Saas Ahmed Naved et al 2011
- •Vasopressor therapy
- •Septic patients
- •Thoracotomy
- •Bogota bag
- •Intravenous Drug Abuser (IVDA) as evidenced by urine toxicology upon admission to the Trauma Unit
- •Patients with prior history of gastric surgery and/or colonic surgery
- •Medical History: of severe cardiovascular disease, Renal diseases, Hepatitis C or Hepatic failure, Autoimmune disease, Crohn and Ulcerative Colitis (In view of the inflammation in the intestinal mucosal which may decrease optimal absorption of the medication) and or bowel obstruction
- •Prior pancreatic anastomosis or gastric anastomosis; ostomy formation
- •Chronic use of nonsteroidal anti-inflammatory drugs
研究组 & 干预措施
Placebo
Patients in the Placebo group will receive a placebo pill and will be compared with the study group
干预措施: Placebo (Drug)
Alvimopan
Patients in the study group will be administered a post operative dose of Alvimopan
干预措施: Alvimopan (Drug)
结局指标
主要结局
Recovery of bowel function in trauma patients who received post operative dose of Alvimopan compared to placebo.
时间窗: 2 years
Since Entereg is a peripherally opioid receptor antagonist it will bind to those receptors and will avoid the post operative ileus hence the bowel recovery will be faster. By physical examination (passage of flatus, bowel movements upon auscultation) will be used to assess recovery of bowel function
次要结局
- Length of stay in patients of the same population who receive a placebo.(5 years)
研究者
Pablo Rodriguez Ortiz
MD
University of Puerto Rico